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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended September 30, 2023
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from ______________ to _______________
Commission
file number: 000-56257
ACCUSTEM
SCIENCES, INC.
(Exact
name of registrant as specified in Its Charter)
Delaware |
|
87-3774438 |
(State
of other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
5
Penn Plaza, 19th Floor, #1954 New York, NY |
|
10001 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: 00 44 2074952379
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
ACUT |
|
OTCQB
Venture Marketplace (“OTCQB”) |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the Registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b 2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
Emerging
growth company |
☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b 2 of the Exchange Act). Yes ☐ No ☒
As
of November 10, 2023, there were 11,346,535 shares of Common Stock, $0.001 par value outstanding.
Table
of Contents
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
ACCUSTEM
SCIENCES INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash | |
$ | 71,010 | | |
$ | 733,978 | |
Prepaid expenses | |
| 181,610 | | |
| 168,430 | |
Other Current Assets | |
| - | | |
| 29,603 | |
Total Current Assets | |
| 252,620 | | |
| 932,011 | |
Equipment, net | |
| 4,955 | | |
| 7,678 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 257,575 | | |
$ | 939,689 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Accounts payable | |
$ | 432,363 | | |
$ | 311,834 | |
Related party payable | |
| 1,132,394 | | |
| 142,229 | |
Accrued expenses | |
| 465,503 | | |
| 518,625 | |
Note Payable | |
| 112,752 | | |
| 106,551 | |
Total Current Liabilities | |
| 2,143,012 | | |
| 1,079,239 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 2,143,012 | | |
| 1,079,239 | |
| |
| | | |
| | |
Stockholders’ Equity | |
| | | |
| | |
Preferred stock $.001 par value; 10,000,000 shares authorized; none issued and outstanding | |
| — | | |
| — | |
Common stock $.001 par value; 150,000,000 shares authorized; 11,346,535 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| 11,346 | | |
| 11,346 | |
Additional paid-in capital | |
| 4,379,120 | | |
| 4,320,385 | |
Accumulated deficit | |
| (6,275,903 | ) | |
| (4,471,281 | ) |
TOTAL STOCKHOLDERS’ EQUITY | |
| (1,885,437 | ) | |
| (139,550 | ) |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 257,575 | | |
$ | 939,689 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ACCUSTEM
SCIENCES INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
$ | 19,951 | | |
$ | 58,270 | | |
$ | 50,128 | | |
$ | 133,809 | |
General and administrative expenses | |
| 578,574 | | |
| 840,855 | | |
| 1,754,494 | | |
| 2,634,076 | |
Total operating expenses | |
| 598,525 | | |
| 899,125 | | |
| 1,804,622 | | |
| 2,767,885 | |
LOSS FROM OPERATIONS | |
| (598,525 | ) | |
| (899,125 | ) | |
| (1,804,622 | ) | |
| (2,767,885 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax benefit (expense) | |
| - | | |
| - | | |
| - | | |
| - | |
NET LOSS | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.05 | ) | |
$ | (0.08 | ) | |
$ | (0.16 | ) | |
$ | (0.25 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | |
| 11,346,535 | | |
| 11,337,668 | | |
| 11,346,535 | | |
| 10,904,423 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ACCUSTEM
SCIENCES INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
For
Three Months Ended September 30, 2023
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | - | |
Accumulated Deficit | | |
Stockholders’ Deficit | |
| |
Common Stock | | |
Additional | | |
| | |
| |
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Stockholders’ Deficit | |
Balance at June 30, 2023 | |
| 11,346,535 | | |
$ | 11,346 | | |
$ | 4,359,220 | - | - |
$ | (5,677,378 | ) | |
$ | (1,306,812 | ) |
Share-based compensation | |
| - | | |
| - | | |
| 19,900 | | |
| - | | |
| 19,900 | |
Net loss | |
| - | | |
| - | | |
| - | - | - |
| (598,525 | ) | |
| (598,525 | ) |
Balance at September 30, 2023 | |
| 11,346,535 | | |
$ | 11,346 | | |
$ | 4,379,120 | - | - |
$ | (6,275,903 | ) | |
$ | (1,885,437 | ) |
For
Three Months Ended September 30, 2022
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Subscription Receivable | | |
Comprehensive Loss | | |
Accumulated Deficit | | |
Stockholders’ Equity | |
| |
Common Stock | | |
Additional | | |
Related Party | | |
Accumulated Other | | |
| | |
| |
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Subscription Receivable | | |
Comprehensive Loss | | |
Accumulated Deficit | | |
Stockholders’ Equity | |
Balance at June 30, 2022 | |
| 11,337,571 | | |
$ | 11,337 | | |
$ | 4,232,851 | | |
| - | | |
| - | | |
$ | (2,593,622 | ) | |
$ | 1,650,566 | |
Share-based compensation | |
| - | | |
| - | | |
| 38,001 | | |
| - | | |
| - | | |
| - | | |
| 38,001 | |
Exercise of common stock options | |
| 8,964 | | |
| 9 | | |
| 8,273 | | |
| - | | |
| - | | |
| - | | |
| 8,282 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (899,125 | ) | |
| (899,125 | ) |
Balance at September 30, 2022 | |
| 11,346,535 | | |
$ | 11,346 | | |
$ | 4,279,125 | | |
| - | | |
| - | | |
$ | (3,492,747 | ) | |
$ | 797,724 | |
For
Nine Months Ended September 30, 2023
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Stockholders’ Deficit | |
| |
Common Stock | | |
Additional | | |
| | |
| |
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Stockholders’ Deficit | |
Balance at December 31, 2022 | |
| 11,346,535 | | |
$ | 11,346 | | |
$ | 4,320,385 | - | - |
$ | (4,471,281 | ) | |
$ | (139,550 | ) |
Share-based compensation | |
| - | | |
| - | | |
| 58,735 | | |
| - | | |
| 58,735 | |
Net loss | |
| - | | |
| - | | |
| - | - | - |
| (1,804,622 | ) | |
| (1,804,622 | ) |
Balance at September 30, 2023 | |
| 11,346,535 | | |
$ | 11,346 | | |
$ | 4,379,120 | - | - |
$ | (6,275,903 | ) | |
$ | (1,885,437 | ) |
For
Nine Months Ended September 30, 2022
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Subscription Receivable | | |
Comprehensive Income | | |
Accumulated Deficit | | |
Stockholders’ Equity | |
| |
Common Stock | | |
Additional | | |
Related Party | | |
Accumulated Other | | |
| | |
| |
| |
Number of Shares | | |
Amount | | |
Paid-in Capital | | |
Subscription Receivable | | |
Comprehensive Income | | |
Accumulated Deficit | | |
Stockholders’ Equity | |
Balance at December 31, 2021 | |
| 9,999,132 | | |
$ | 9,999 | | |
$ | 1,503,434 | | |
$ | (204,879 | ) | |
$ | 66,981 | | |
$ | (724,862 | ) | |
$ | 650,673 | |
Share-based compensation | |
| - | | |
| - | | |
| 92,629 | | |
| - | | |
| - | | |
| - | | |
| 92,629 | |
Issuance of common stock | |
| 1,337,970 | | |
| 1,338 | | |
| 2,674,602 | | |
| - | | |
| - | | |
| - | | |
| 2,675,940 | |
Receipt of subscription receivable | |
| - | | |
| - | | |
| - | | |
| 204,879 | | |
| - | | |
| - | | |
| 204,879 | |
Exercise of common stock options | |
| 9,433 | | |
| 9 | | |
| 8,460 | | |
| - | | |
| - | | |
| - | | |
| 8,469 | |
Foreign currency translation adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| (66,981 | ) | |
| - | | |
| (66,981 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,767,885 | ) | |
| (2,767,885 | ) |
Balance at September 30, 2022 | |
| 11,346,535 | | |
$ | 11,346 | | |
$ | 4,279,125 | | |
| - | | |
| - | | |
$ | (3,492,747 | ) | |
$ | 797,724 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ACCUSTEM
SCIENCES INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2023 | | |
2022 | |
| |
For the Nine Months Ended September 30 | |
| |
2023 | | |
2022 | |
Operating Activities | |
| | | |
| | |
Net loss | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
| |
| | | |
| | |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities | |
| | | |
| | |
Foreign currency translation | |
| - | | |
| (66,981 | ) |
Depreciation | |
| 2,723 | | |
| 2,414 | |
Share-based compensation | |
| 58,735 | | |
| 92,629 | |
Change in operating assets and liabilities: | |
| | | |
| | |
Related party receivable | |
| - | | |
| 1,353,373 | |
Prepaid expenses | |
| 269,880 | | |
| 157,009 | |
Other current assets | |
| 29,603 | | |
| - | |
Accounts payable | |
| 120,529 | | |
| (233,791 | ) |
Related party payable | |
| 49,500 | | |
| 49,500 | |
Accrued expenses | |
| (46,960 | ) | |
| 229,940 | |
Net cash used in operating activities | |
| (1,320,612 | ) | |
| (1,183,792 | ) |
| |
| | | |
| | |
Investing Activities | |
| | | |
| | |
Purchases of equipment | |
| - | | |
| (10,999 | ) |
Net cash used in investing activities | |
| - | | |
| (10,999 | ) |
| |
| | | |
| | |
Financing Activities | |
| | | |
| | |
Advances from related party | |
| 940,665 | | |
| 59,305 | |
Payments on advances from related party | |
| | | |
| (190,838 | ) |
Proceeds from receipt of subscription receivable | |
| - | | |
| 204,879 | |
Proceeds from issuance of common stock | |
| - | | |
| 2,675,940 | |
Proceeds from exercise of options | |
| - | | |
| 8,469 | |
Payments on note payable | |
| (283,021 | ) | |
| (231,004 | ) |
Net cash provided by financing activities | |
| 657,644 | | |
| 2,526,751 | |
| |
| | | |
| | |
(Decrease) Increase in cash | |
| (662,968 | ) | |
| 1,331,960 | |
| |
| | | |
| | |
Cash, beginning of period | |
| 733,978 | | |
| - | |
Cash, end of period | |
$ | 71,010 | | |
$ | 1,331,960 | |
| |
| | | |
| | |
Supplemental disclosure of noncash investing and financing activities | |
| | | |
| | |
Issuance of Note Payable for payment of prepaid expense | |
| 372,879 | | |
| 439,122 | |
Amendment of Issuance of Note Payable for payment of prepaid expense | |
| (89,818 | ) | |
| - | |
Supplemental cash flow information | |
| | | |
| | |
Cash paid for interest | |
| 4,728 | | |
| 5,726 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ACCUSTEM
SCIENCES INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
DESCRIPTION OF BUSINESS
AccuStem
Sciences, Inc. is an early-stage life sciences company committed to developing and commercializing novel products for the treatment and
management of many cancers. The principal activities of the Company are that of a genomics-based personalized medicine business, particularly
focused on breast and lung cancer patients.
Liquidity
and Going Concern
The
condensed consolidated financial statements have been prepared on the going concern basis, which contemplates the realization of assets
and discharge of liabilities in the normal course of business. The Company has financed its activities principally from support from
a related party. The Company has incurred a net loss in every fiscal period since inception. For the nine months ended September 30,
2023, the Company incurred a net loss of $1,804,622. The Company has an accumulated deficit of $6,275,903 as of September 30, 2023. The
Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding,
further development of its technology and products, and expenses related to the commercialization of its products.
Management
believes that the Company does not have sufficient cash and current assets to support its operations through at least 12 months from
the issuance date of these condensed consolidated financial statements, and will require significant additional cash resources to continue
its planned research and development activities.
The
Company will need additional funds for promoting new products and working capital required to support research and development activities
and generate sales from its products. There can be no assurance, however, that such financing will be available when needed, if at all,
or on favorable terms and conditions. The precise amount and timing of the funding needs cannot be determined accurately at this time,
and will depend on a number of factors, including the quality of product development efforts, management of working capital, and the
continuation of normal payment terms and conditions for purchase of services.
In
order to address its capital needs, including its planned research and development activities and other expenditures, the Company is
actively pursuing additional equity financing in the form of a private investment and public equity. The Company has been in ongoing
discussions with institutional investors and other parties with respect to such possible offerings. Adequate financing opportunities
might not be available to the Company, when and if needed, on acceptable terms or at all. If the Company is unable to obtain additional
financing in sufficient amounts or on acceptable terms or if the Company fails to consummate the private placement or a public offering,
the Company will be forced to delay, reduce or eliminate some or all of its research and development programs and product portfolio expansion,
which could adversely affect its operating results or business prospects. Although management continues to pursue these plans, there
is no assurance that the Company will be successful in obtaining sufficient funding in terms acceptable to the Company to fund continuing
operations, if at all. After considering the uncertainties, management determined it is appropriate to continue to adopt the going concern
basis in preparing the condensed consolidated financial statements.
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
principal accounting policies applied in the preparation of these condensed consolidated financial statements are set out below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting
Principles (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”)
regarding interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in
accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on February 15, 2023. Unless otherwise indicated, all
references to “$” are to U.S. dollars, and all references to “£” or “GBP” are to Great Britain
Pounds. The Company’s reporting currency is U.S. dollars.
Basis
of Consolidation
The
condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary after elimination of
intercompany transactions and balances.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management of the Company to make estimates and assumptions that
affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and
expenses during the reporting period. Actual results could differ from those estimates.
Risk
and Uncertainties
The
Company is subject to a number of risks similar to those of other companies of similar size in its industry, including but not limited
to, the success of its exploration to research and development activities, need for additional capital (or financing) to fund operating
losses, competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation,
dependence on key individuals, and risks associated with changes in information technology.
Cash
The
Company considers all highly liquid investments purchased with an original maturity date of three months or less at the date of purchase
and money market accounts to be cash equivalents. At September 30, 2023 and December 31, 2022, the Company had no cash equivalents and
all cash amounts consisted of cash on deposit.
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to significant contribution of credit risk consist of cash. Periodically, the Company
maintains deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed
to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high
credit quality and the Company has not experienced any losses in these deposits.
Equipment,
net
Equipment
is stated at cost, less accumulated depreciation. The Company depreciates its equipment for financial reporting purposes using the straight-line
method over the estimated useful lives of the assets. The Equipment consists of computer equipment, which has a useful life of 3 years.
Maintenance and repairs are expensed when incurred. Additions and improvements that extend the economic useful life of the asset are
capitalized and depreciated over the remaining useful lives of the assets. The cost and accumulated depreciation of assets sold or retired
are removed from the respective accounts, and any resulting gain or loss is reflected in current earnings.
Share-based
Compensation
The
Company may award stock options, performance-based options and other equity-based instruments to its employees, directors and consultants.
Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized
over the requisite service period on a straight-line basis over the vesting period except for performance-based options. Performance-based
stock options vest based on the achievement of performance targets. Compensation costs associated with performance-based option awards
are recognized over the requisite service period based on probability of achievement. Performance-based stock options require management
to make assumptions regarding the likelihood of achieving performance targets.
The
Company estimates the fair value of service based and performance-based stock option awards, including modifications of stock option
awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions
related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.
Reclassification
Certain
2022 amounts have been reclassified, where appropriate, to conform to the 2023 presentation.
Recent
Accounting Standards
Adopted
Accounting Standards
None
Standards
not yet adopted
None
3.
EQUIPMENT
Equipment
consists of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
September 30, 2023 | | |
December 31, 2022 | |
Computer equipment | |
$ | 10,999 | | |
| 10,999 | |
Less: Accumulated depreciation | |
| 6,044 | | |
| 3,321 | |
Equipment, net | |
$ | 4,955 | | |
| 7,678 | |
Depreciation
expense was approximately $907 for the three months ended September 30, 2023 and 2022, respectively. For the nine months ended September
30, 2023 and 2022, respectively, depreciation expense was approximately $2,723 and $2,414, respectively.
Depreciation
expense is included within General and Administrative expenses in the accompanying Condensed Consolidated Statement of Operations.
4.
ACCRUED EXPENSES
Accrued
expenses consist of the following:
SCHEDULE OF ACCRUED EXPENSES
| |
September 30, 2023 | | |
December 31, 2022 | |
Corporate bonus | |
$ | 272,603 | | |
| 369,528 | |
Legal expense | |
| 147,006 | | |
| 124,245 | |
Other | |
| 45,894 | | |
| 24,852 | |
Total accrued expenses | |
$ | 465,503 | | |
$ | 518,625 | |
5.
NOTE PAYABLE
On
May 20, 2023, the Company renewed its Directors and Officers Liability Insurance agreement for $372,880.
Under the terms of the agreement, the Company made a down payment of $75,000,
with the remaining balance financed over the remaining term at an annual percentage rate of 7.50%.
Beginning June 2023, the Company will make 10 monthly payments of $30,822,
with the last payment expected to be made in March 2024. In August 2023, the Company amended the agreement, which reduced the
monthly payment from $30,822
to $18,792.
At the end of September 30, 2023, the outstanding balance on the note payable was $112,752.
6.
LICENSE
On
November 9, 2022, AccuStem and the IEO/University of Milan amended the License to clarify the regulatory path and timeline for the commercialization
of StemPrintER. Specifically, the regulatory requirement language has been modified to (i) extend the timeline for regulatory approval
or clearance of a licensed product to 36 months from the date of the amendment, (ii) clarify that contractual regulatory requirements
can be satisfied by the approval or clearance of the test as a Laboratory Developed Test (i.e., approval or clearance can be achieved
via the CLIA regulatory path rather than the FDA) and (iii) the timeline for commercial launch has been extended for an additional 60
months from the date of the amendment. The amendment provides for a separate licensing payment of $175,000 to the IEO.
In
addition, for the term of the license, the following milestone payments are required to be made (converted from EUROS to USD using exchange
rate of €1:$1.0675)
|
● |
€50,000
($53,375) within 30 days of completion of development of a commercial test; |
|
● |
€100,000
($106,750) within 30 days of the first commercial sale of a licensed product; and |
|
● |
€150,000
($160,125) within 30 days of first regulatory approval in the U.S. or any other major market. |
The
License may be terminated by either party in the event of a material breach and in addition, we may terminate the License at any time
upon 30 days’ notice.
For
the three and nine months ended September 30, 2023 and 2022, the Company did not recognize any expense related to this license agreement.
7.
LOSS PER SHARE
Basic
and diluted net loss per common share were the same since the inclusion of common shares issuable pursuant to the exercise of options
in the calculation of diluted net loss per common shares would have been antidilutive.
For
the three and nine months ended September 30, 2023 and 2022, loss per share of the Company are as follows:
SCHEDULE OF LOSS PER SHARE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
Net loss per share attributable to common stockholders | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 11,346,535 | | |
| 11,337,668 | | |
| 11,346,535 | | |
| 10,904,423 | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.05 | ) | |
$ | (0.08 | ) | |
$ | (0.16 | ) | |
$ | (0.25 | ) |
The
Company’s potentially dilutive securities, which include stock options and warrants, have been excluded from the computation of
diluted net loss per common share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of
common shares outstanding used to calculate both basic and diluted net loss per share attributable to common shareholders is the same.
The
Company excluded the following from the computation of diluted net loss per share attributable to common stockholders for the three months
and nine months ended September 30, 2023 and 2022 because including them would have had an anti-dilutive effect.
SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Shares issuable upon exercise of stock options | |
| 1,261,115 | | |
| 1,397,811 | | |
| 1,261,115 | | |
| 1,397,811 | |
Warrants to purchase common stock outstanding | |
| 350,000 | | |
| 350,000 | | |
| 350,000 | | |
| 350,000 | |
Total | |
| 1,611,115 | | |
| 1,747,811 | | |
| 1,611,115 | | |
| 1,747,811 | |
8.
SHARE-BASED COMPENSATION
In
August 2021, AccuStem adopted the 2021 Omnibus Equity Incentive Plan (the “Incentive Plan”). The Incentive Plan provides
that the Company may grant Options, Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, and Other Share-Based Awards
to selected employees, directors, and independent contractors of the Company.
Each
Award shall be exercisable at such time or times and subject to such terms and conditions set forth in the Incentive Plan, as shall be
determined by the administrator in the applicable award agreement. Total shares authorized by the Incentive Plan was 2,500,000. Awards
under the Incentive Plan are exercisable for up to 10 years from the date of issuance. There are 1,229,452 remaining available shares
to be issued under the Incentive Plan at September 30, 2023. The number of shares of Common Stock that are reserved and available for
issuance under the Incentive Plan shall be subject to an annual increase on the first day of each calendar year beginning with the first
January 1 following the effective date and ending with the last January 1 during the initial ten-year term of the Plan as defined in
Section 4(a) of the Incentive Plan.
Options
There
were no options granted or modified for the three and nine months ended September 30, 2023, and for the three months ended September
30, 2022.
The
Company issued 1,307,239 options during the first quarter of 2022 for employees, directors and non-employees under the Incentive Plan.
The options granted had an exercise price ranging from $1.06 to $2.13 and expire on the ten-year anniversary of the grant date.
For
the nine months ended September 30, 2022, stock option activity for time-based options of the Company are as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
|
|
Number
of
Time-Based
Share
Options |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted
Average
Remaining
Contractual
Life
(in years) |
|
|
Aggregate
Intrinsic
Value |
|
Outstanding
at January 1, 2022 |
|
|
100,005 |
|
|
$ |
0.42 |
|
|
|
9.72 |
|
|
$ |
— |
|
Issued |
|
|
363,239 |
|
|
|
2.07 |
|
|
|
9.43 |
|
|
|
— |
|
Exercised |
|
|
(9,433 |
) |
|
|
0.90 |
|
|
|
— |
|
|
|
— |
|
Expired/Forfeited |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Outstanding
at September 30, 2022 |
|
|
453,811 |
|
|
$ |
1.70 |
|
|
|
9.30 |
|
|
$ |
16,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested
and exercisable September 30, 2022 |
|
|
207,825 |
|
|
$ |
1.20 |
|
|
|
9.14 |
|
|
$ |
16,672 |
|
For
the nine months ended September 30, 2022, stock option activity for performance-based options of the Company are as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
Number
of Performance- Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Issued | |
| 944,000 | | |
| 1.45 | | |
| 9.36 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2022 | |
| 944,000 | | |
$ | 1.45 | | |
| 9.36 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2022 | |
| — | | |
| — | | |
| — | | |
| — | |
For
the nine months ended September 30, 2023, stock option activity for time-based options of the Company are as follows:
| |
Number
of Time-Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 416,115 | | |
$ | 1.86 | | |
| 9.13 | | |
$ | 57,207 | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| (49,500 | ) | |
| 2.13 | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 366,615 | | |
$ | 1.82 | | |
| 8.40 | | |
$ | 27,384 | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| 119,765 | | |
$ | 1.29 | | |
| 8.22 | | |
$ | 27,384 | |
For
the nine months ended September 30, 2023, stock option activity for performance-based options of the Company are as follows:
| |
Number
of Performance- Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 944,000 | | |
$ | 1.45 | | |
| 9.11 | | |
$ | 174,000 | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| (49,500 | ) | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 894,500 | | |
$ | 1.41 | | |
| 8.36 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| — | | |
| — | | |
| — | | |
| — | |
The
aggregate intrinsic value is calculated as the difference between the estimated fair value of the underlying common stock as of September
30, 2023 and the option exercise price.
Total
share-based compensation was approximately $19,900 and $38,001, respectively, for the three months ended September 30, 2023 and 2022,
respectively. For the nine months ended September 30, 2023 and 2022, respectively, share-based compensation was approximately $58,735
and $92,629, respectively.
Total
share-based compensation expense is included in General and Administrative expenses on the Condensed Consolidated Statement of Operations.
There
was no time based or performance -based stock option granted during the nine months ended September 30, 2023.
The
weighted average grant date fair value for stock options granted during the nine months ended September 30, 2022 is $0.76. The performance-based
and time-based stock options are equity-classified.
The
Company uses the Black-Scholes option pricing model to estimate the fair value of the option awards. The table below summarizes the resulting
weighted average inputs used to calculate the estimated fair value of options awarded for the nine months ended September 30, 2023 and
2022.
SCHEDULE OF STOCK VALUATION ASSUMPTIONS
| |
| Nine
Months Ended
September
30, 2023 | | |
| Nine
Months Ended
September
30, 2022 | |
Risk-free
interest rate | |
| — | | |
| 1.54
- 2.34 | % |
Expected
dividend yield | |
| — | | |
| — | % |
Expected
term | |
| — | | |
| 5.00
– 8.50 years | |
Expected
volatility | |
| — | | |
| 57.2
- 65.7 | % |
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero- coupon issues with a remaining
term commensurate with the expected term of the award. The Company has historically been a private company and lacks company-specific
historical and implied volatility information. Management has estimated expected volatility based on similar public companies. Expected
life of the option represents the period of time options are expected to be outstanding. The estimate for dividend yield is 0% because
the Company has not historically paid, and does not intend to pay, a dividend on common stock in the foreseeable future.
As
of September 30, 2023, there was $772,580 unrecognized compensation expense related to options. $102,213 of this cost is subject to time-based
conditions, and is to be recognized over a period of approximately 2.6 years. The remaining $670,368 of unrecognized compensation expense
relates to performance-based conditions for unvested options. These costs are expected to be recognized over the required service period
once the performance condition has occurred or becomes probable. Compensation costs related to the performance stock options are evaluated
at each reporting period and subsequently adjusted for changes in the expected outcomes of the performance conditions.
Warrants
In
March 2022, the Company issued 350,000 common stock warrants to a non-employee under the Incentive Plan. The common stock warrants are
subject to vesting and, grantees become fully vested and exercisable when certain performance requirements are met.
The
common stock warrants granted have an exercise price of $1.06. The common stock warrants expire on the ten-year anniversary of the grant
date. There were no warrants issued during the three months ended September 30, 2023 and 2022.
For
the nine months ended September 30, 2022, warrant activity of the Company are as follows:
SCHEDULE OF WARRANTS OUTSTANDING
| |
Number
of shares | | |
Weighted Average Exercise
Price | | |
Weighted average remaining contractual life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Issued | |
| 350,000 | | |
| 1.06 | | |
| 9.32 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2022 | |
| 350,000 | | |
$ | 1.06 | | |
| 9.32 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2022 | |
| — | | |
| — | | |
| — | | |
| — | |
For
the nine months ended September 30, 2023, warrant activity of the Company are as follows:
| |
Number
of shares | | |
Weighted Average Exercise
Price | | |
Weighted average remaining contractual life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 350,000 | | |
$ | 1.06 | | |
| 9.07 | | |
$ | — | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 350,000 | | |
$ | 1.06 | | |
| 8.32 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| — | | |
| — | | |
| — | | |
| — | |
The
grant date fair value for these warrants of $0.66 per warrant for a total fair value of $232,490. The table below summarizes the resulting
weighted average inputs used to calculate the estimated fair value of the common stock warrants options awarded for the nine months ended
September 30, 2023 and 2022.
SCHEDULE OF STOCK VALUATION ASSUMPTIONS
| |
Nine
Months Ended
September
30, 2023 | | |
Nine
Months Ended
September
30, 2022 | |
Risk-free
interest rate | |
| — | | |
| 1.75 | % |
Expected
dividend yield | |
| — | | |
| — | % |
Expected
term | |
| — | | |
| 8.50
years | |
Expected
volatility | |
| — | | |
| 63.9 | % |
There
was no share-based compensation expense recognized during the three and nine months ended September 30, 2023 and 2022 for warrants.
As
of September 30, 2023, there was $232,490 of total performance-based unrecognized compensation costs related to unvested common stock
warrants. These costs are expected to be recognized once the performance condition has occurred or becomes probable.
9.
RELATED PARTY TRANSACTIONS
Tiziana
Life Sciences Limited (“Tiziana”) is a related party as it is under common control. The Company and Tiziana share directors,
officers and significant shareholders. The Company has also been formed due to an acquisition of a subsidiary company from Tiziana. As
of September 30, 2023, Tiziana owns approximately 11.8% of the Company.
Effective
with the demerger agreement, the Company entered into a shared services agreement, where the Company outsources certain limited management
and administrative services. The Company notes that the fees consist of payroll costs associated with time spent providing services for
the Company and are based on actual time spent and the allocated payroll costs. In addition, the Company is charged, at cost, for utilization
of certain office space. There was no mark-up associated with fees charged for these services. For the three months ended September 30,
2023 and 2022, the Company has incurred approximately $4,955 and $4,708, respectively.
As
of September 30, 2023 and December 31, 2022, $1,016,894 and $76,229 respectively, was also due to Tiziana, as Tiziana had paid for expenses
on behalf of the Company. Subsequent to September 30, 2023, Tiziana had paid for an additional $70,000 of expenses on behalf of the Company.
In
January 2022, the Company and Gabriele Cerrone, who is the Chairman of the Board of Directors and the largest shareholder, entered into
an agreement in which he will provide consulting services to the Company for a monthly fee of $5,500. As of September 30, 2023, $115,500
was due to Gabriele Cerrone.
10.
INCOME TAXES
The
Company recorded no provision or benefit for income tax expense for the three months ended September 30, 2023. For all periods presented,
the pretax losses incurred by the Company received no corresponding tax benefit because the Company concluded that it is more likely
than not that the Company will be unable to realize the value of any resulting deferred tax assets. The Company will continue to assess
its position in future periods to determine if it is appropriate to reduce a portion of its valuation allowance in the future.
The
Company has no open tax audits with any taxing authority as of September 30, 2023.
Item
2: Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated
financial statements and the related notes included elsewhere in this Form 10-Q and with our audited consolidated financial statements
included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on February 15, 2023. In addition
to our historical condensed consolidated financial information, the following contains forward-looking statements that reflect our plans,
estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that
could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q (this “Form 10-Q”) contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended
to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions
and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,”
“expect,” “may,” “will,” “should,” “would,” “could,” “seek,”
“intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,”
“strategy,” “future,” “likely” or the negative thereof or other variations thereon or other comparable
terminology. All statements other than statements of historical facts included in this Form 10-Q regarding our strategies, prospects,
financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include,
but are not limited to, statements we make regarding: expectations for revenues, cash flows and financial performance and the anticipated
results of our ongoing development and business strategies.
Forward-looking
statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy
and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks
and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those
indicated in the forward-looking statements include, but are not limited to, the following:
|
● |
the
success, cost and timing of our clinical development of our products, including the progress of, and results from, our preclinical
and |
|
● |
clinical
trials of StemPrintER products, our discovery programs and other potential product candidates; |
|
● |
our
ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings
in the label of any of our product candidates, if approved; |
|
● |
our
ability to compete with companies currently marketing or engaged in the development of treatments for indications that our product
candidates are designed to target; |
|
● |
our
plans to pursue research and development of other future product candidates; |
|
● |
the
potential advantages of our product candidates and those being developed; |
|
● |
the
rate and degree of market acceptance and clinical utility of our product candidates; |
|
● |
the
success of our collaborations and partnerships with third parties; |
|
● |
our
estimates regarding the potential market opportunity for our product candidates; |
|
● |
our
sales, marketing and distribution capabilities and strategy; |
|
● |
our
ability to establish and maintain arrangements for manufacture of our product candidates; |
|
● |
our
intellectual property position; |
|
● |
our
expectations related to the use of capital; |
|
● |
the
effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our
business operations, including but not limited to our preclinical studies and future clinical trials; |
|
● |
our
estimates regarding expenses, future revenues, capital requirements and needs for additional financing; |
|
● |
the
impact of government laws and regulations; and |
|
● |
our
competitive position. |
The
forward-looking statements are based upon management’s beliefs and assumptions and are made as of the date of this report. We undertake
no obligation to publicly update or revise any forward-looking statements included in this report. You should not place undue reliance
on these forward-looking statements.
This
report also contains or may contain estimates, projections and other information concerning our industry and our business, including
data regarding the estimated size of our markets and their projected growth rates. Information that is based on estimates, forecasts,
projections, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially
from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business,
market and other data from reports, studies and similar data prepared by third parties, industry and general publications, government
data and similar sources. In some cases, we do not expressly refer to the sources from which these data are derived.
Unless
otherwise stated or the context otherwise requires, the terms “AccuStem” “we,” “us,” “our”
and the “Company” refer collectively to AccuStem and, where appropriate, its subsidiaries.
Overview
We
are a clinical stage diagnostics company dedicated to improving quality of life and outcomes for the more than 18 million people worldwide
who are diagnosed with cancer each year. Our plan is to develop and commercialize a suite of novel genomic tests that support decision
making along the entire continuum of oncology care. Our focus will be the commercialization of our proprietary genomic test, StemPrintER,
for patients with early-stage breast cancer, and we estimate this market opportunity represents more than $1.3 billion in annual revenue.
Our
primary product candidate is StemPrintER, a 20-gene prognostic assay intended to predict the risk of distant recurrence (“DR”)
in luminal (ER+/HER2-negative) breast cancer patients. The assay was developed to measure the “stemness” of tumors, or how
much a tumor behaves like stem cells which could indicate how likely a cancer is to recur or be resistant to standard treatments, ultimately
impacting how patients are managed by their multi-disciplinary care team. StemPrintER has been validated in several clinical cohorts
and studies, the largest of which are a consecutive series of approximately 2,400 patients from the European Institute of Oncology (“IEO”)
and approximately 800 patients from the TransATAC study. In the IEO cohort, StemPrintER High Risk patients (“SPRS High”)
were 1.85 times more likely to have a distant recurrence compared to Low Risk (“SPRS Low”) patients (Figure 1) and in the
TransATAC cohort, SPRS High patients were 4.27 times more likely to experience a distant recurrence compared to SPRS Low Risk patients
(Figure 2). Together, these data confirm that StemPrintER is highly prognostic for outcomes in patients with breast cancer and indicate
the potential utility of the test in the oncology clinic.
*SPRS-
StemPrintER Recurrence Score; SPRS High- StemPrintER High Risk; SPRS Low- StemPrintER Low Risk
Beyond
our initial plans for StemPrintER, we believe there is significant opportunity to expand our product portfolio. First, given the broad
applicability of tumor “stemness”, which has been evaluated in a multitude of different cancers, we believe the StemPrint
platform will have meaningful clinical utility beyond breast cancer. As such, we will seek to validate and commercialize StemPrint for
a variety of different tumor types. Each tumor type, where applicable, would also include ancillary testing to boost our value proposition
to physicians and their patients. In addition, we plan to offer ancillary commodity testing (e.g., hereditary genetic testing, somatic
mutation testing) that augments our proprietary assays and provides additional information and value to patients and physicians throughout
the patient care continuum.
We
plan to launch StemPrintER once we have achieved several key milestones. First, we plan to identify or build a laboratory that will be
responsible for processing, testing and reporting StemPrintER results for all commercial samples. Further, we plan to transfer the StemPrintER
assay from the laboratories in which they were developed to our commercial laboratory. Finally, upon establishing testing capabilities
in our commercial laboratory, we will seek to obtain U.S. Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certification
so that we are able to report results for clinical use and to seek reimbursement from the Centers for Medicare and Medicaid Services.
We anticipate that it will take at least 18 months to complete these milestones. Once those tasks are complete, we plan to initially
launch StemPrintER in the US and then expand to other markets as we evaluate clinical need and revenue opportunity.
Financial
Operations Overview
We
have no products approved for commercial sale and have not generated revenue to date. We have never been profitable and have incurred
net losses in each year since inception. We incurred net losses of $598,525 and $899,125 for the three months ended September 30, 2023
and 2022, respectively. We incurred net losses of $1,804,622 and $2,767,885 for the nine months ended September 30, 2023 and 2022, respectively.
As of September 30, 2023, we had an accumulated deficit of $6,275,903. Substantially all of our net losses resulted from expenses incurred
in connection with our research and development programs and from general and administrative costs associated with our operations.
Segment
Information
As
of September 30, 2023, we viewed our operations and managed our business as one operating segment consistent with how our chief operating
decision maker, our Chief Executive Officer, makes decisions regarding resource allocation and assessing performance. As of September
30, 2023, substantially all of our assets were located in the United States. Our headquarters and operations are located in New York,
NY and London, UK.
Results
of Operations
The
following discussion and analysis of our results of operations includes a comparison of the three and nine months ended September 30,
2023 to the three and nine months ended September 30, 2022:
| |
Three
Months Ended September
30 | | |
| | |
| | |
Nine
Months Ended September
30 | | |
| | |
| |
| |
2023 | | |
2022 | | |
$
Change | | |
%
Change | | |
2023 | | |
2022 | | |
$
Change | | |
%
Change | |
Research
and development expenses | |
$ | 19,951 | | |
$ | 58,270 | | |
$ | (38,319 | ) | |
| -66 | % | |
$ | 50,128 | | |
$ | 133,809 | | |
$ | (83,681 | ) | |
| -63 | % |
General
and administrative expenses | |
| 578,574 | | |
| 840,855 | | |
| (262,281 | ) | |
| -31 | % | |
| 1,754,494 | | |
| 2,634,076 | | |
| (879,852 | ) | |
| -33 | % |
Loss
from operations | |
| 598,525 | | |
| 899,125 | | |
| (300,600 | ) | |
| -33 | % | |
| 1,804,622 | | |
| 2,767,885 | | |
| (963,263 | ) | |
| -35 | % |
Loss,
before income tax | |
| (598,525 | ) | |
| (899,125 | ) | |
| 300,600 | | |
| -33 | % | |
| (1,804,622 | ) | |
| (2,767,885 | ) | |
| 963,263 | | |
| -35 | % |
Income
tax benefit (expense) | |
| - | | |
| - | | |
| - | | |
| 0 | % | |
| - | | |
| - | | |
| - | | |
| 0 | % |
Net
Loss | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | 300,600 | | |
| -33 | % | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) | |
$ | 963,263 | | |
| -35 | % |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Research
and development
Research
and development expenses for the three and nine months ended September 30, 2023 decreased to $19,951 and $50,128, respectively, compared
to $58,270 and $133,809, respectively, for the three and nine months ended September 30, 2022 primarily due to a decrease in patent related
expenses, and laboratory work and consulting.
General
and administrative
General
and administrative expenses for the three and nine months ended September 30, 2023 decreased to $578,574 and $1,754,494, respectively,
compared to $840,855 and $2,634,076, respectively, for the three and nine months ended September 30, 2022 primarily due to a decrease
of payroll related costs as a result of changes in management, legal fees and other compliance expenses.
Liquidity
and Capital Resources
Sources
of Liquidity
Since
our inception, we have not generated any revenue and have incurred significant operating losses. Our potential products are at various
phases of development. We do not expect to generate significant revenue from product sales for several years, if at all. Pursuant to
the demerger, Tiziana transferred $1,353,373 (£1,000,000) in cash in January 2022 to us. In addition, subject to the terms of the
supplemental demerger agreement, Tiziana invested $2,675,940 (£2,000,000) in cash in March 2022 for additional shares of the Company.
Our cash flows may fluctuate and are difficult to forecast and will depend on many factors. As of September 30, 2023, our cash balance
is $71,010, which is not adequate for our current planned level of operations through at least 12 months from the issuance date of these
condensed consolidated financial statements.
Cash
Flows
The
following table summarizes our cash flows:
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows used in operating activities | |
$ | (1,320,612 | ) | |
$ | (1,183,792 | ) |
| |
| | | |
| | |
Cash flows used in investing activities | |
| — | | |
| (10,999 | ) |
| |
| | | |
| | |
Cash flows provided by financing activities | |
| 657,644 | | |
| 2,526,751 | |
| |
| | | |
| | |
Net (decrease) increase in cash and cash equivalents | |
| (662,968 | ) | |
| 1,331,960 | |
Cash and cash equivalents at beginning of period | |
| 733,978 | | |
| — | |
Cash and cash equivalents at end of period | |
$ | 71,010 | | |
$ | 1,331,960 | |
Operating
Activities
During
the nine months ended September 30, 2023, net cash used in operating activities was primarily the result of net losses, partially offset
by prepaid expenses and accounts payable.
During
the nine months ended September 30, 2022, net cash used in operating activities was primarily the result of net losses, partially offset
by the collection of a receivable from a related party.
Investing
Activities
There
were no cash flows from investing activities during the nine months ended September 30, 2023.
The
cash flow used in investing activities increased during the nine months ended September 30, 2022 was due to the purchase of computer
equipment.
Financing
Activities
During
the nine months ended September 30, 2023, net cash provided by financing activities was primarily due to advances from a related party,
partially offset by payments on a note payable.
We
generated cash flows from financing activities during the nine months ended September 30, 2022 due to proceeds from the issuance of common
stock to Tiziana.
Market
Capital Expenditure Commitments
We
have no material commitment for capital expenditures.
Funding
Requirements
We
expect that our expenses will increase and operating losses will be generated, and we have $6,275,903 of accumulated deficit as at September
30, 2023. Based on our current plans, we believe our existing cash and cash equivalents will not be sufficient to fund our operations
and capital expenditure requirements through at least 12 months from the issuance date of these condensed consolidated financial statements.
We expect to incur substantial additional expenditures in the near term to support our acceleration of activities. We expect to incur
net losses for the foreseeable future. Our ability to fund our product development and clinical operations as well as commercialization
of our product candidates, will depend on the amount and timing of cash received from planned financings. Our future capital requirements
will depend on many factors, including:
|
● |
the
costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates; |
|
|
|
|
● |
the
costs of commercialization activities, including product marketing, sales and distribution; |
|
|
|
|
● |
the
costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related
claims; |
|
|
|
|
● |
the
emergence of competing technologies and products and other adverse marketing developments; |
|
|
|
|
● |
the
effect on our product development activities of actions taken by the FDA, EMA or other regulatory authorities; |
|
|
|
|
● |
our
degree of success in commercializing our product candidates, if and when approved; and |
|
|
|
|
● |
the
number and types of future products we develop and commercialize. |
A
change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly
change the costs and timing associated with the development of that product candidate. Further, our operating plans may change in the
future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity
financings, debt financings, collaborations with other companies or other strategic transactions. We do not currently have any committed
external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your
ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect
your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include
covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital
expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution
or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams,
research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional
funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our
research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would
otherwise prefer to develop and market ourselves.
Further,
our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials
and other research and development activities. We currently have no credit facility or committed sources of capital. Because of the numerous
risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the
amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
Critical
Accounting Policies
There
have been no significant changes to our critical accounting policies and estimates from the information provided in Item 7, “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” included in our Form 10-K for the year ended December
31, 2022.
Off-Balance
Sheet Arrangements
We
have no other off-balance sheet arrangements that have had, or are reasonably likely to have, a material current or future effect on
our consolidated financial statements or changes in financial condition, revenues or expenses, results of operations, liquidity, capital
expenditures or capital resources.
Recent
Accounting Pronouncements
For
information on recent accounting pronouncements, see our condensed consolidated financial statements - Note 2 and the related notes found
elsewhere in this quarterly report.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
There
have been no significant changes to our quantitative and qualitative disclosures about market risk as discussed in Part II, Item 7A “Quantitative
and Qualitative Disclosures About Market Risk,” included our Form 10-K for the year ended December 31, 2022.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our “disclosure controls and procedures” (as defined in Exchange Act Rules 13a-15I and 15d-15(e)) as of September 30, 2023,
the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures” as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure
that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized
and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it
files under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer
and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within a company have been detected. Based on the evaluation of our
disclosure controls and procedures as of September 30, 2023, our management, with the participation of our principal executive officer
and principal financial officer has concluded that, based on such evaluation, as of the end of the period covered by this Quarterly Report
on Form 10-Q, our disclosure controls and procedures were not effective due to the material weakness described below.
Material
Weaknesses in Internal Controls Over Financial Reporting
A
material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such that there is
a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected
on a timely basis.
Management
has determined that we did not maintain effective internal control over financial reporting as of the period ended September 30, 2023
due to a lack of accounting resources resulting in inadequate monitoring controls and other oversight procedures. Our management has
determined that our disclosure controls and procedures and internal controls were ineffective due to weaknesses in our financial closing
process, inadequate segregation of duties over authorization, review and recording of transactions, lack of accounting resources, as
well as the financial reporting of such transactions.
Management’s
Plan to Remediate the Material Weakness
Management
intends to remediate this item in the following manner:
i.
Recruit appropriately skilled accounting resources (the “Remediation Plan”)
Accordingly,
management has determined that these control deficiencies constitute a material weakness. Management has begun implementing the Remediation
Plan described herein and intends to continue working on it through the year ended December 31, 2023.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting during the quarter ended September 30, 2023 that has materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
There
have been no material changes to the risk factors previously disclosed in our Form 10-K for the year ended December 31, 2022
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
Applicable.
Item
5. Other Information
None.
Item
6. Exhibits
31.1
Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act
31.2
Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act
32.1
Certification by Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
Certification by Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*
Inline XBRL Instance Document
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned, thereunto duly authorized on November 13, 2023.
|
ACCUSTEM
SCIENCES, INC. |
|
|
|
/s/
Keeren Shah |
|
Keeren
Shah |
|
Chief
Financial Officer |
In
accordance with the Securities Exchange Act of 1934, this Report has been signed below on November 13, 2023 by the following persons
on behalf of the Registrant and in the capacities indicated.
/s/
Wendy Blosser |
|
Wendy
Blosser |
|
Chief
Executive Officer and Director |
|
|
|
/s/
Keeren Shah |
|
Keeren
Shah |
|
Chief
Financial Officer |
|
Exhibit
31.1
CERTIFICATION
BY PRINCIPAL EXECUTIVE OFFICER, PRINCIPAL FINANCIAL AND
ACCOUNTING
OFFICER
I,
Wendy Blosser, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of AccuStem Sciences Inc.; |
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Dated:
November 13, 2023
|
/s/
Wendy Blosser |
|
Name: |
Wendy
Blosser |
|
Title: |
Chief
Executive Officer |
|
Exhibit
31.2
CERTIFICATION
BY PRINCIPAL EXECUTIVE OFFICER, PRINCIPAL FINANCIAL AND
ACCOUNTING
OFFICER
I,
Keeren Shah, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of AccuStem Sciences Inc.; |
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Dated:
November 13, 2023
|
/s/
Keeren Shah |
|
Name: |
Keeren
Shah |
|
Title: |
Chief
Financial Officer |
|
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the quarterly report of AccuStem Sciences Inc. (the “Company”) on Form 10-Q for the period ended September
30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Wendy Blosser, Chief
Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley
Act of 2002, that:
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of
the Company.
Dated:
November 13, 2023
|
/s/
Wendy Blosser |
|
Name: |
Wendy
Blosser |
|
Title: |
Chief
Executive Officer |
|
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Annual Report of AccuStem Sciences Inc. (the “Company”) on Form 10-Q for the period ended September 30,
2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Keeren Shah, Chief Financial
Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002,
that:
(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of
the Company.
Dated:
November 13, 2023
|
/s/
Keeren Shah |
|
Name: |
Keeren
Shah |
|
Title: |
Chief
Financial Officer |
|
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 10, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
000-56257
|
|
Entity Registrant Name |
ACCUSTEM
SCIENCES, INC.
|
|
Entity Central Index Key |
0001850767
|
|
Entity Tax Identification Number |
87-3774438
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
5
Penn Plaza
|
|
Entity Address, Address Line Two |
19th Floor
|
|
Entity Address, City or Town |
#1954 New York
|
|
Entity Address, State or Province |
NY
|
|
Entity Address, Postal Zip Code |
10001
|
|
City Area Code |
00 44
|
|
Local Phone Number |
2074952379
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
ACUT
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
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11,346,535
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v3.23.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current Assets |
|
|
Cash |
$ 71,010
|
$ 733,978
|
Prepaid expenses |
181,610
|
168,430
|
Other Current Assets |
|
29,603
|
Total Current Assets |
252,620
|
932,011
|
Equipment, net |
4,955
|
7,678
|
TOTAL ASSETS |
257,575
|
939,689
|
Current Liabilities |
|
|
Accounts payable |
432,363
|
311,834
|
Related party payable |
1,132,394
|
142,229
|
Accrued expenses |
465,503
|
518,625
|
Note Payable |
112,752
|
106,551
|
Total Current Liabilities |
2,143,012
|
1,079,239
|
TOTAL LIABILITIES |
2,143,012
|
1,079,239
|
Stockholders’ Equity |
|
|
Preferred stock $.001 par value; 10,000,000 shares authorized; none issued and outstanding |
|
|
Common stock $.001 par value; 150,000,000 shares authorized; 11,346,535 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
11,346
|
11,346
|
Additional paid-in capital |
4,379,120
|
4,320,385
|
Accumulated deficit |
(6,275,903)
|
(4,471,281)
|
TOTAL STOCKHOLDERS’ EQUITY |
(1,885,437)
|
(139,550)
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 257,575
|
$ 939,689
|
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v3.23.3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
150,000,000
|
150,000,000
|
Common stock shares issued |
11,346,535
|
11,346,535
|
Common stock shares outstanding |
11,346,535
|
11,346,535
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
OPERATING EXPENSES |
|
|
|
|
Research and development expenses |
$ 19,951
|
$ 58,270
|
$ 50,128
|
$ 133,809
|
General and administrative expenses |
578,574
|
840,855
|
1,754,494
|
2,634,076
|
Total operating expenses |
598,525
|
899,125
|
1,804,622
|
2,767,885
|
LOSS FROM OPERATIONS |
(598,525)
|
(899,125)
|
(1,804,622)
|
(2,767,885)
|
LOSS, BEFORE TAX |
(598,525)
|
(899,125)
|
(1,804,622)
|
(2,767,885)
|
Income tax benefit (expense) |
|
|
|
|
NET LOSS |
$ (598,525)
|
$ (899,125)
|
$ (1,804,622)
|
$ (2,767,885)
|
Net loss per share attributable to common stockholders, basic |
$ (0.05)
|
$ (0.08)
|
$ (0.16)
|
$ (0.25)
|
Net loss per share attributable to common stockholders, diluted |
$ (0.05)
|
$ (0.08)
|
$ (0.16)
|
$ (0.25)
|
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, basic |
11,346,535
|
11,337,668
|
11,346,535
|
10,904,423
|
Weighted average common shares outstanding used in computing net loss per share attributable to common stockholders, diluted |
11,346,535
|
11,337,668
|
11,346,535
|
10,904,423
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
Condensed Consolidated Statements of Changes in StockHolders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Related Party Subscription Receivable [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 9,999
|
$ 1,503,434
|
$ (204,879)
|
$ 66,981
|
$ (724,862)
|
$ 650,673
|
Beginning balance, shares at Dec. 31, 2021 |
9,999,132
|
|
|
|
|
|
Share-based compensation |
|
92,629
|
|
|
|
92,629
|
Net loss |
|
|
|
|
(2,767,885)
|
(2,767,885)
|
Exercise of common stock options |
$ 9
|
8,460
|
|
|
|
8,469
|
Exercise of common stock options, shares |
9,433
|
|
|
|
|
|
Issuance of common stock |
$ 1,338
|
2,674,602
|
|
|
|
2,675,940
|
Issuance of common stock, shares |
1,337,970
|
|
|
|
|
|
Receipt of subscription receivable |
|
|
204,879
|
|
|
204,879
|
Foreign currency translation adjustment |
|
|
|
(66,981)
|
|
(66,981)
|
Ending balance, value at Sep. 30, 2022 |
$ 11,346
|
4,279,125
|
|
|
(3,492,747)
|
797,724
|
Ending balance, shares at Sep. 30, 2022 |
11,346,535
|
|
|
|
|
|
Beginning balance, value at Jun. 30, 2022 |
$ 11,337
|
4,232,851
|
|
|
(2,593,622)
|
1,650,566
|
Beginning balance, shares at Jun. 30, 2022 |
11,337,571
|
|
|
|
|
|
Share-based compensation |
|
38,001
|
|
|
|
38,001
|
Net loss |
|
|
|
|
(899,125)
|
(899,125)
|
Exercise of common stock options |
$ 9
|
8,273
|
|
|
|
8,282
|
Exercise of common stock options, shares |
8,964
|
|
|
|
|
|
Ending balance, value at Sep. 30, 2022 |
$ 11,346
|
4,279,125
|
|
|
(3,492,747)
|
797,724
|
Ending balance, shares at Sep. 30, 2022 |
11,346,535
|
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 11,346
|
4,320,385
|
|
|
(4,471,281)
|
(139,550)
|
Beginning balance, shares at Dec. 31, 2022 |
11,346,535
|
|
|
|
|
|
Share-based compensation |
|
58,735
|
|
|
|
58,735
|
Net loss |
|
|
|
|
(1,804,622)
|
(1,804,622)
|
Ending balance, value at Sep. 30, 2023 |
$ 11,346
|
4,379,120
|
|
|
(6,275,903)
|
(1,885,437)
|
Ending balance, shares at Sep. 30, 2023 |
11,346,535
|
|
|
|
|
|
Beginning balance, value at Jun. 30, 2023 |
$ 11,346
|
4,359,220
|
|
|
(5,677,378)
|
(1,306,812)
|
Beginning balance, shares at Jun. 30, 2023 |
11,346,535
|
|
|
|
|
|
Share-based compensation |
|
19,900
|
|
|
|
19,900
|
Net loss |
|
|
|
|
(598,525)
|
(598,525)
|
Ending balance, value at Sep. 30, 2023 |
$ 11,346
|
$ 4,379,120
|
|
|
$ (6,275,903)
|
$ (1,885,437)
|
Ending balance, shares at Sep. 30, 2023 |
11,346,535
|
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating Activities |
|
|
Net loss |
$ (1,804,622)
|
$ (2,767,885)
|
Adjustments to reconcile net loss to net cash (used in) provided by operating activities |
|
|
Foreign currency translation |
|
(66,981)
|
Depreciation |
2,723
|
2,414
|
Share-based compensation |
58,735
|
92,629
|
Change in operating assets and liabilities: |
|
|
Related party receivable |
|
1,353,373
|
Prepaid expenses |
269,880
|
157,009
|
Other current assets |
29,603
|
|
Accounts payable |
120,529
|
(233,791)
|
Related party payable |
49,500
|
49,500
|
Accrued expenses |
(46,960)
|
229,940
|
Net cash used in operating activities |
(1,320,612)
|
(1,183,792)
|
Investing Activities |
|
|
Purchases of equipment |
|
(10,999)
|
Net cash used in investing activities |
|
(10,999)
|
Financing Activities |
|
|
Advances from related party |
940,665
|
59,305
|
Payments on advances from related party |
|
(190,838)
|
Proceeds from receipt of subscription receivable |
|
204,879
|
Proceeds from issuance of common stock |
|
2,675,940
|
Proceeds from exercise of options |
|
8,469
|
Payments on note payable |
(283,021)
|
(231,004)
|
Net cash provided by financing activities |
657,644
|
2,526,751
|
(Decrease) Increase in cash |
(662,968)
|
1,331,960
|
Cash, beginning of period |
733,978
|
|
Cash, end of period |
71,010
|
1,331,960
|
Supplemental disclosure of noncash investing and financing activities |
|
|
Issuance of Note Payable for payment of prepaid expense |
372,879
|
439,122
|
Amendment of Issuance of Note Payable for payment of prepaid expense |
(89,818)
|
|
Supplemental cash flow information |
|
|
Cash paid for interest |
$ 4,728
|
$ 5,726
|
X |
- DefinitionAmendment of Issuance of Note Payable for payment of prepaid expense.
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v3.23.3
DESCRIPTION OF BUSINESS
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
DESCRIPTION OF BUSINESS |
1.
DESCRIPTION OF BUSINESS
AccuStem
Sciences, Inc. is an early-stage life sciences company committed to developing and commercializing novel products for the treatment and
management of many cancers. The principal activities of the Company are that of a genomics-based personalized medicine business, particularly
focused on breast and lung cancer patients.
Liquidity
and Going Concern
The
condensed consolidated financial statements have been prepared on the going concern basis, which contemplates the realization of assets
and discharge of liabilities in the normal course of business. The Company has financed its activities principally from support from
a related party. The Company has incurred a net loss in every fiscal period since inception. For the nine months ended September 30,
2023, the Company incurred a net loss of $1,804,622. The Company has an accumulated deficit of $6,275,903 as of September 30, 2023. The
Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding,
further development of its technology and products, and expenses related to the commercialization of its products.
Management
believes that the Company does not have sufficient cash and current assets to support its operations through at least 12 months from
the issuance date of these condensed consolidated financial statements, and will require significant additional cash resources to continue
its planned research and development activities.
The
Company will need additional funds for promoting new products and working capital required to support research and development activities
and generate sales from its products. There can be no assurance, however, that such financing will be available when needed, if at all,
or on favorable terms and conditions. The precise amount and timing of the funding needs cannot be determined accurately at this time,
and will depend on a number of factors, including the quality of product development efforts, management of working capital, and the
continuation of normal payment terms and conditions for purchase of services.
In
order to address its capital needs, including its planned research and development activities and other expenditures, the Company is
actively pursuing additional equity financing in the form of a private investment and public equity. The Company has been in ongoing
discussions with institutional investors and other parties with respect to such possible offerings. Adequate financing opportunities
might not be available to the Company, when and if needed, on acceptable terms or at all. If the Company is unable to obtain additional
financing in sufficient amounts or on acceptable terms or if the Company fails to consummate the private placement or a public offering,
the Company will be forced to delay, reduce or eliminate some or all of its research and development programs and product portfolio expansion,
which could adversely affect its operating results or business prospects. Although management continues to pursue these plans, there
is no assurance that the Company will be successful in obtaining sufficient funding in terms acceptable to the Company to fund continuing
operations, if at all. After considering the uncertainties, management determined it is appropriate to continue to adopt the going concern
basis in preparing the condensed consolidated financial statements.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
principal accounting policies applied in the preparation of these condensed consolidated financial statements are set out below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting
Principles (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”)
regarding interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in
accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on February 15, 2023. Unless otherwise indicated, all
references to “$” are to U.S. dollars, and all references to “£” or “GBP” are to Great Britain
Pounds. The Company’s reporting currency is U.S. dollars.
Basis
of Consolidation
The
condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary after elimination of
intercompany transactions and balances.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management of the Company to make estimates and assumptions that
affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and
expenses during the reporting period. Actual results could differ from those estimates.
Risk
and Uncertainties
The
Company is subject to a number of risks similar to those of other companies of similar size in its industry, including but not limited
to, the success of its exploration to research and development activities, need for additional capital (or financing) to fund operating
losses, competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation,
dependence on key individuals, and risks associated with changes in information technology.
Cash
The
Company considers all highly liquid investments purchased with an original maturity date of three months or less at the date of purchase
and money market accounts to be cash equivalents. At September 30, 2023 and December 31, 2022, the Company had no cash equivalents and
all cash amounts consisted of cash on deposit.
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to significant contribution of credit risk consist of cash. Periodically, the Company
maintains deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed
to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high
credit quality and the Company has not experienced any losses in these deposits.
Equipment,
net
Equipment
is stated at cost, less accumulated depreciation. The Company depreciates its equipment for financial reporting purposes using the straight-line
method over the estimated useful lives of the assets. The Equipment consists of computer equipment, which has a useful life of 3 years.
Maintenance and repairs are expensed when incurred. Additions and improvements that extend the economic useful life of the asset are
capitalized and depreciated over the remaining useful lives of the assets. The cost and accumulated depreciation of assets sold or retired
are removed from the respective accounts, and any resulting gain or loss is reflected in current earnings.
Share-based
Compensation
The
Company may award stock options, performance-based options and other equity-based instruments to its employees, directors and consultants.
Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized
over the requisite service period on a straight-line basis over the vesting period except for performance-based options. Performance-based
stock options vest based on the achievement of performance targets. Compensation costs associated with performance-based option awards
are recognized over the requisite service period based on probability of achievement. Performance-based stock options require management
to make assumptions regarding the likelihood of achieving performance targets.
The
Company estimates the fair value of service based and performance-based stock option awards, including modifications of stock option
awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions
related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.
Reclassification
Certain
2022 amounts have been reclassified, where appropriate, to conform to the 2023 presentation.
Recent
Accounting Standards
Adopted
Accounting Standards
None
Standards
not yet adopted
None
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v3.23.3
EQUIPMENT
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
EQUIPMENT |
3.
EQUIPMENT
Equipment
consists of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
September 30, 2023 | | |
December 31, 2022 | |
Computer equipment | |
$ | 10,999 | | |
| 10,999 | |
Less: Accumulated depreciation | |
| 6,044 | | |
| 3,321 | |
Equipment, net | |
$ | 4,955 | | |
| 7,678 | |
Depreciation
expense was approximately $907 for the three months ended September 30, 2023 and 2022, respectively. For the nine months ended September
30, 2023 and 2022, respectively, depreciation expense was approximately $2,723 and $2,414, respectively.
Depreciation
expense is included within General and Administrative expenses in the accompanying Condensed Consolidated Statement of Operations.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.3
ACCRUED EXPENSES
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
4.
ACCRUED EXPENSES
Accrued
expenses consist of the following:
SCHEDULE OF ACCRUED EXPENSES
| |
September 30, 2023 | | |
December 31, 2022 | |
Corporate bonus | |
$ | 272,603 | | |
| 369,528 | |
Legal expense | |
| 147,006 | | |
| 124,245 | |
Other | |
| 45,894 | | |
| 24,852 | |
Total accrued expenses | |
$ | 465,503 | | |
$ | 518,625 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.3
NOTE PAYABLE
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
NOTE PAYABLE |
5.
NOTE PAYABLE
On
May 20, 2023, the Company renewed its Directors and Officers Liability Insurance agreement for $372,880.
Under the terms of the agreement, the Company made a down payment of $75,000,
with the remaining balance financed over the remaining term at an annual percentage rate of 7.50%.
Beginning June 2023, the Company will make 10 monthly payments of $30,822,
with the last payment expected to be made in March 2024. In August 2023, the Company amended the agreement, which reduced the
monthly payment from $30,822
to $18,792.
At the end of September 30, 2023, the outstanding balance on the note payable was $112,752.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.23.3
LICENSE
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
LICENSE |
6.
LICENSE
On
November 9, 2022, AccuStem and the IEO/University of Milan amended the License to clarify the regulatory path and timeline for the commercialization
of StemPrintER. Specifically, the regulatory requirement language has been modified to (i) extend the timeline for regulatory approval
or clearance of a licensed product to 36 months from the date of the amendment, (ii) clarify that contractual regulatory requirements
can be satisfied by the approval or clearance of the test as a Laboratory Developed Test (i.e., approval or clearance can be achieved
via the CLIA regulatory path rather than the FDA) and (iii) the timeline for commercial launch has been extended for an additional 60
months from the date of the amendment. The amendment provides for a separate licensing payment of $175,000 to the IEO.
In
addition, for the term of the license, the following milestone payments are required to be made (converted from EUROS to USD using exchange
rate of €1:$1.0675)
|
● |
€50,000
($53,375) within 30 days of completion of development of a commercial test; |
|
● |
€100,000
($106,750) within 30 days of the first commercial sale of a licensed product; and |
|
● |
€150,000
($160,125) within 30 days of first regulatory approval in the U.S. or any other major market. |
The
License may be terminated by either party in the event of a material breach and in addition, we may terminate the License at any time
upon 30 days’ notice.
For
the three and nine months ended September 30, 2023 and 2022, the Company did not recognize any expense related to this license agreement.
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v3.23.3
LOSS PER SHARE
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
LOSS PER SHARE |
7.
LOSS PER SHARE
Basic
and diluted net loss per common share were the same since the inclusion of common shares issuable pursuant to the exercise of options
in the calculation of diluted net loss per common shares would have been antidilutive.
For
the three and nine months ended September 30, 2023 and 2022, loss per share of the Company are as follows:
SCHEDULE OF LOSS PER SHARE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
Net loss per share attributable to common stockholders | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 11,346,535 | | |
| 11,337,668 | | |
| 11,346,535 | | |
| 10,904,423 | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.05 | ) | |
$ | (0.08 | ) | |
$ | (0.16 | ) | |
$ | (0.25 | ) |
The
Company’s potentially dilutive securities, which include stock options and warrants, have been excluded from the computation of
diluted net loss per common share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of
common shares outstanding used to calculate both basic and diluted net loss per share attributable to common shareholders is the same.
The
Company excluded the following from the computation of diluted net loss per share attributable to common stockholders for the three months
and nine months ended September 30, 2023 and 2022 because including them would have had an anti-dilutive effect.
SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Shares issuable upon exercise of stock options | |
| 1,261,115 | | |
| 1,397,811 | | |
| 1,261,115 | | |
| 1,397,811 | |
Warrants to purchase common stock outstanding | |
| 350,000 | | |
| 350,000 | | |
| 350,000 | | |
| 350,000 | |
Total | |
| 1,611,115 | | |
| 1,747,811 | | |
| 1,611,115 | | |
| 1,747,811 | |
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v3.23.3
SHARE-BASED COMPENSATION
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
SHARE-BASED COMPENSATION |
8.
SHARE-BASED COMPENSATION
In
August 2021, AccuStem adopted the 2021 Omnibus Equity Incentive Plan (the “Incentive Plan”). The Incentive Plan provides
that the Company may grant Options, Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, and Other Share-Based Awards
to selected employees, directors, and independent contractors of the Company.
Each
Award shall be exercisable at such time or times and subject to such terms and conditions set forth in the Incentive Plan, as shall be
determined by the administrator in the applicable award agreement. Total shares authorized by the Incentive Plan was 2,500,000. Awards
under the Incentive Plan are exercisable for up to 10 years from the date of issuance. There are 1,229,452 remaining available shares
to be issued under the Incentive Plan at September 30, 2023. The number of shares of Common Stock that are reserved and available for
issuance under the Incentive Plan shall be subject to an annual increase on the first day of each calendar year beginning with the first
January 1 following the effective date and ending with the last January 1 during the initial ten-year term of the Plan as defined in
Section 4(a) of the Incentive Plan.
Options
There
were no options granted or modified for the three and nine months ended September 30, 2023, and for the three months ended September
30, 2022.
The
Company issued 1,307,239 options during the first quarter of 2022 for employees, directors and non-employees under the Incentive Plan.
The options granted had an exercise price ranging from $1.06 to $2.13 and expire on the ten-year anniversary of the grant date.
For
the nine months ended September 30, 2022, stock option activity for time-based options of the Company are as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
|
|
Number
of
Time-Based
Share
Options |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted
Average
Remaining
Contractual
Life
(in years) |
|
|
Aggregate
Intrinsic
Value |
|
Outstanding
at January 1, 2022 |
|
|
100,005 |
|
|
$ |
0.42 |
|
|
|
9.72 |
|
|
$ |
— |
|
Issued |
|
|
363,239 |
|
|
|
2.07 |
|
|
|
9.43 |
|
|
|
— |
|
Exercised |
|
|
(9,433 |
) |
|
|
0.90 |
|
|
|
— |
|
|
|
— |
|
Expired/Forfeited |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Outstanding
at September 30, 2022 |
|
|
453,811 |
|
|
$ |
1.70 |
|
|
|
9.30 |
|
|
$ |
16,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested
and exercisable September 30, 2022 |
|
|
207,825 |
|
|
$ |
1.20 |
|
|
|
9.14 |
|
|
$ |
16,672 |
|
For
the nine months ended September 30, 2022, stock option activity for performance-based options of the Company are as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
Number
of Performance- Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Issued | |
| 944,000 | | |
| 1.45 | | |
| 9.36 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2022 | |
| 944,000 | | |
$ | 1.45 | | |
| 9.36 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2022 | |
| — | | |
| — | | |
| — | | |
| — | |
For
the nine months ended September 30, 2023, stock option activity for time-based options of the Company are as follows:
| |
Number
of Time-Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 416,115 | | |
$ | 1.86 | | |
| 9.13 | | |
$ | 57,207 | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| (49,500 | ) | |
| 2.13 | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 366,615 | | |
$ | 1.82 | | |
| 8.40 | | |
$ | 27,384 | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| 119,765 | | |
$ | 1.29 | | |
| 8.22 | | |
$ | 27,384 | |
For
the nine months ended September 30, 2023, stock option activity for performance-based options of the Company are as follows:
| |
Number
of Performance- Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 944,000 | | |
$ | 1.45 | | |
| 9.11 | | |
$ | 174,000 | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| (49,500 | ) | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 894,500 | | |
$ | 1.41 | | |
| 8.36 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| — | | |
| — | | |
| — | | |
| — | |
The
aggregate intrinsic value is calculated as the difference between the estimated fair value of the underlying common stock as of September
30, 2023 and the option exercise price.
Total
share-based compensation was approximately $19,900 and $38,001, respectively, for the three months ended September 30, 2023 and 2022,
respectively. For the nine months ended September 30, 2023 and 2022, respectively, share-based compensation was approximately $58,735
and $92,629, respectively.
Total
share-based compensation expense is included in General and Administrative expenses on the Condensed Consolidated Statement of Operations.
There
was no time based or performance -based stock option granted during the nine months ended September 30, 2023.
The
weighted average grant date fair value for stock options granted during the nine months ended September 30, 2022 is $0.76. The performance-based
and time-based stock options are equity-classified.
The
Company uses the Black-Scholes option pricing model to estimate the fair value of the option awards. The table below summarizes the resulting
weighted average inputs used to calculate the estimated fair value of options awarded for the nine months ended September 30, 2023 and
2022.
SCHEDULE OF STOCK VALUATION ASSUMPTIONS
| |
| Nine
Months Ended
September
30, 2023 | | |
| Nine
Months Ended
September
30, 2022 | |
Risk-free
interest rate | |
| — | | |
| 1.54
- 2.34 | % |
Expected
dividend yield | |
| — | | |
| — | % |
Expected
term | |
| — | | |
| 5.00
– 8.50 years | |
Expected
volatility | |
| — | | |
| 57.2
- 65.7 | % |
The
risk-free interest rate assumption is determined using the yield currently available on U.S. Treasury zero- coupon issues with a remaining
term commensurate with the expected term of the award. The Company has historically been a private company and lacks company-specific
historical and implied volatility information. Management has estimated expected volatility based on similar public companies. Expected
life of the option represents the period of time options are expected to be outstanding. The estimate for dividend yield is 0% because
the Company has not historically paid, and does not intend to pay, a dividend on common stock in the foreseeable future.
As
of September 30, 2023, there was $772,580 unrecognized compensation expense related to options. $102,213 of this cost is subject to time-based
conditions, and is to be recognized over a period of approximately 2.6 years. The remaining $670,368 of unrecognized compensation expense
relates to performance-based conditions for unvested options. These costs are expected to be recognized over the required service period
once the performance condition has occurred or becomes probable. Compensation costs related to the performance stock options are evaluated
at each reporting period and subsequently adjusted for changes in the expected outcomes of the performance conditions.
Warrants
In
March 2022, the Company issued 350,000 common stock warrants to a non-employee under the Incentive Plan. The common stock warrants are
subject to vesting and, grantees become fully vested and exercisable when certain performance requirements are met.
The
common stock warrants granted have an exercise price of $1.06. The common stock warrants expire on the ten-year anniversary of the grant
date. There were no warrants issued during the three months ended September 30, 2023 and 2022.
For
the nine months ended September 30, 2022, warrant activity of the Company are as follows:
SCHEDULE OF WARRANTS OUTSTANDING
| |
Number
of shares | | |
Weighted Average Exercise
Price | | |
Weighted average remaining contractual life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Issued | |
| 350,000 | | |
| 1.06 | | |
| 9.32 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2022 | |
| 350,000 | | |
$ | 1.06 | | |
| 9.32 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2022 | |
| — | | |
| — | | |
| — | | |
| — | |
For
the nine months ended September 30, 2023, warrant activity of the Company are as follows:
| |
Number
of shares | | |
Weighted Average Exercise
Price | | |
Weighted average remaining contractual life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 350,000 | | |
$ | 1.06 | | |
| 9.07 | | |
$ | — | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 350,000 | | |
$ | 1.06 | | |
| 8.32 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| — | | |
| — | | |
| — | | |
| — | |
The
grant date fair value for these warrants of $0.66 per warrant for a total fair value of $232,490. The table below summarizes the resulting
weighted average inputs used to calculate the estimated fair value of the common stock warrants options awarded for the nine months ended
September 30, 2023 and 2022.
SCHEDULE OF STOCK VALUATION ASSUMPTIONS
| |
Nine
Months Ended
September
30, 2023 | | |
Nine
Months Ended
September
30, 2022 | |
Risk-free
interest rate | |
| — | | |
| 1.75 | % |
Expected
dividend yield | |
| — | | |
| — | % |
Expected
term | |
| — | | |
| 8.50
years | |
Expected
volatility | |
| — | | |
| 63.9 | % |
There
was no share-based compensation expense recognized during the three and nine months ended September 30, 2023 and 2022 for warrants.
As
of September 30, 2023, there was $232,490 of total performance-based unrecognized compensation costs related to unvested common stock
warrants. These costs are expected to be recognized once the performance condition has occurred or becomes probable.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
RELATED PARTY TRANSACTIONS
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
9.
RELATED PARTY TRANSACTIONS
Tiziana
Life Sciences Limited (“Tiziana”) is a related party as it is under common control. The Company and Tiziana share directors,
officers and significant shareholders. The Company has also been formed due to an acquisition of a subsidiary company from Tiziana. As
of September 30, 2023, Tiziana owns approximately 11.8% of the Company.
Effective
with the demerger agreement, the Company entered into a shared services agreement, where the Company outsources certain limited management
and administrative services. The Company notes that the fees consist of payroll costs associated with time spent providing services for
the Company and are based on actual time spent and the allocated payroll costs. In addition, the Company is charged, at cost, for utilization
of certain office space. There was no mark-up associated with fees charged for these services. For the three months ended September 30,
2023 and 2022, the Company has incurred approximately $4,955 and $4,708, respectively.
As
of September 30, 2023 and December 31, 2022, $1,016,894 and $76,229 respectively, was also due to Tiziana, as Tiziana had paid for expenses
on behalf of the Company. Subsequent to September 30, 2023, Tiziana had paid for an additional $70,000 of expenses on behalf of the Company.
In
January 2022, the Company and Gabriele Cerrone, who is the Chairman of the Board of Directors and the largest shareholder, entered into
an agreement in which he will provide consulting services to the Company for a monthly fee of $5,500. As of September 30, 2023, $115,500
was due to Gabriele Cerrone.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
INCOME TAXES
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
10.
INCOME TAXES
The
Company recorded no provision or benefit for income tax expense for the three months ended September 30, 2023. For all periods presented,
the pretax losses incurred by the Company received no corresponding tax benefit because the Company concluded that it is more likely
than not that the Company will be unable to realize the value of any resulting deferred tax assets. The Company will continue to assess
its position in future periods to determine if it is appropriate to reduce a portion of its valuation allowance in the future.
The
Company has no open tax audits with any taxing authority as of September 30, 2023.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting
Principles (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”)
regarding interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in
accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on February 15, 2023. Unless otherwise indicated, all
references to “$” are to U.S. dollars, and all references to “£” or “GBP” are to Great Britain
Pounds. The Company’s reporting currency is U.S. dollars.
|
Basis of Consolidation |
Basis
of Consolidation
The
condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary after elimination of
intercompany transactions and balances.
|
Use of Estimates |
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management of the Company to make estimates and assumptions that
affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and
expenses during the reporting period. Actual results could differ from those estimates.
|
Risk and Uncertainties |
Risk
and Uncertainties
The
Company is subject to a number of risks similar to those of other companies of similar size in its industry, including but not limited
to, the success of its exploration to research and development activities, need for additional capital (or financing) to fund operating
losses, competition from substitute products and services from larger companies, protection of proprietary technology, patent litigation,
dependence on key individuals, and risks associated with changes in information technology.
|
Cash |
Cash
The
Company considers all highly liquid investments purchased with an original maturity date of three months or less at the date of purchase
and money market accounts to be cash equivalents. At September 30, 2023 and December 31, 2022, the Company had no cash equivalents and
all cash amounts consisted of cash on deposit.
|
Concentrations of Credit Risk |
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to significant contribution of credit risk consist of cash. Periodically, the Company
maintains deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed
to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high
credit quality and the Company has not experienced any losses in these deposits.
|
Equipment, net |
Equipment,
net
Equipment
is stated at cost, less accumulated depreciation. The Company depreciates its equipment for financial reporting purposes using the straight-line
method over the estimated useful lives of the assets. The Equipment consists of computer equipment, which has a useful life of 3 years.
Maintenance and repairs are expensed when incurred. Additions and improvements that extend the economic useful life of the asset are
capitalized and depreciated over the remaining useful lives of the assets. The cost and accumulated depreciation of assets sold or retired
are removed from the respective accounts, and any resulting gain or loss is reflected in current earnings.
|
Share-based Compensation |
Share-based
Compensation
The
Company may award stock options, performance-based options and other equity-based instruments to its employees, directors and consultants.
Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized
over the requisite service period on a straight-line basis over the vesting period except for performance-based options. Performance-based
stock options vest based on the achievement of performance targets. Compensation costs associated with performance-based option awards
are recognized over the requisite service period based on probability of achievement. Performance-based stock options require management
to make assumptions regarding the likelihood of achieving performance targets.
The
Company estimates the fair value of service based and performance-based stock option awards, including modifications of stock option
awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions
related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.
|
Reclassification |
Reclassification
Certain
2022 amounts have been reclassified, where appropriate, to conform to the 2023 presentation.
|
Recent Accounting Standards |
Recent
Accounting Standards
Adopted
Accounting Standards
None
Standards
not yet adopted
None
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v3.23.3
EQUIPMENT (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
Equipment
consists of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
September 30, 2023 | | |
December 31, 2022 | |
Computer equipment | |
$ | 10,999 | | |
| 10,999 | |
Less: Accumulated depreciation | |
| 6,044 | | |
| 3,321 | |
Equipment, net | |
$ | 4,955 | | |
| 7,678 | |
|
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v3.23.3
ACCRUED EXPENSES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
Accrued
expenses consist of the following:
SCHEDULE OF ACCRUED EXPENSES
| |
September 30, 2023 | | |
December 31, 2022 | |
Corporate bonus | |
$ | 272,603 | | |
| 369,528 | |
Legal expense | |
| 147,006 | | |
| 124,245 | |
Other | |
| 45,894 | | |
| 24,852 | |
Total accrued expenses | |
$ | 465,503 | | |
$ | 518,625 | |
|
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v3.23.3
LOSS PER SHARE (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
SCHEDULE OF LOSS PER SHARE |
For
the three and nine months ended September 30, 2023 and 2022, loss per share of the Company are as follows:
SCHEDULE OF LOSS PER SHARE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
Net loss per share attributable to common stockholders | |
$ | (598,525 | ) | |
$ | (899,125 | ) | |
$ | (1,804,622 | ) | |
$ | (2,767,885 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 11,346,535 | | |
| 11,337,668 | | |
| 11,346,535 | | |
| 10,904,423 | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.05 | ) | |
$ | (0.08 | ) | |
$ | (0.16 | ) | |
$ | (0.25 | ) |
|
SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE |
The
Company excluded the following from the computation of diluted net loss per share attributable to common stockholders for the three months
and nine months ended September 30, 2023 and 2022 because including them would have had an anti-dilutive effect.
SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30 | | |
Nine Months Ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Shares issuable upon exercise of stock options | |
| 1,261,115 | | |
| 1,397,811 | | |
| 1,261,115 | | |
| 1,397,811 | |
Warrants to purchase common stock outstanding | |
| 350,000 | | |
| 350,000 | | |
| 350,000 | | |
| 350,000 | |
Total | |
| 1,611,115 | | |
| 1,747,811 | | |
| 1,611,115 | | |
| 1,747,811 | |
|
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v3.23.3
SHARE-BASED COMPENSATION (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF STOCK VALUATION ASSUMPTIONS |
SCHEDULE OF STOCK VALUATION ASSUMPTIONS
| |
| Nine
Months Ended
September
30, 2023 | | |
| Nine
Months Ended
September
30, 2022 | |
Risk-free
interest rate | |
| — | | |
| 1.54
- 2.34 | % |
Expected
dividend yield | |
| — | | |
| — | % |
Expected
term | |
| — | | |
| 5.00
– 8.50 years | |
Expected
volatility | |
| — | | |
| 57.2
- 65.7 | % |
|
SCHEDULE OF WARRANTS OUTSTANDING |
For
the nine months ended September 30, 2022, warrant activity of the Company are as follows:
SCHEDULE OF WARRANTS OUTSTANDING
| |
Number
of shares | | |
Weighted Average Exercise
Price | | |
Weighted average remaining contractual life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Issued | |
| 350,000 | | |
| 1.06 | | |
| 9.32 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2022 | |
| 350,000 | | |
$ | 1.06 | | |
| 9.32 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2022 | |
| — | | |
| — | | |
| — | | |
| — | |
For
the nine months ended September 30, 2023, warrant activity of the Company are as follows:
| |
Number
of shares | | |
Weighted Average Exercise
Price | | |
Weighted average remaining contractual life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 350,000 | | |
$ | 1.06 | | |
| 9.07 | | |
$ | — | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 350,000 | | |
$ | 1.06 | | |
| 8.32 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| — | | |
| — | | |
| — | | |
| — | |
|
Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF STOCK VALUATION ASSUMPTIONS |
SCHEDULE OF STOCK VALUATION ASSUMPTIONS
| |
Nine
Months Ended
September
30, 2023 | | |
Nine
Months Ended
September
30, 2022 | |
Risk-free
interest rate | |
| — | | |
| 1.75 | % |
Expected
dividend yield | |
| — | | |
| — | % |
Expected
term | |
| — | | |
| 8.50
years | |
Expected
volatility | |
| — | | |
| 63.9 | % |
|
Time Based Options [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF STOCK OPTION ACTIVITY |
For
the nine months ended September 30, 2022, stock option activity for time-based options of the Company are as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
|
|
Number
of
Time-Based
Share
Options |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted
Average
Remaining
Contractual
Life
(in years) |
|
|
Aggregate
Intrinsic
Value |
|
Outstanding
at January 1, 2022 |
|
|
100,005 |
|
|
$ |
0.42 |
|
|
|
9.72 |
|
|
$ |
— |
|
Issued |
|
|
363,239 |
|
|
|
2.07 |
|
|
|
9.43 |
|
|
|
— |
|
Exercised |
|
|
(9,433 |
) |
|
|
0.90 |
|
|
|
— |
|
|
|
— |
|
Expired/Forfeited |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Outstanding
at September 30, 2022 |
|
|
453,811 |
|
|
$ |
1.70 |
|
|
|
9.30 |
|
|
$ |
16,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested
and exercisable September 30, 2022 |
|
|
207,825 |
|
|
$ |
1.20 |
|
|
|
9.14 |
|
|
$ |
16,672 |
|
For
the nine months ended September 30, 2023, stock option activity for time-based options of the Company are as follows:
| |
Number
of Time-Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 416,115 | | |
$ | 1.86 | | |
| 9.13 | | |
$ | 57,207 | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| (49,500 | ) | |
| 2.13 | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 366,615 | | |
$ | 1.82 | | |
| 8.40 | | |
$ | 27,384 | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| 119,765 | | |
$ | 1.29 | | |
| 8.22 | | |
$ | 27,384 | |
|
Performance Based Options [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF STOCK OPTION ACTIVITY |
For
the nine months ended September 30, 2022, stock option activity for performance-based options of the Company are as follows:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
Number
of Performance- Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Issued | |
| 944,000 | | |
| 1.45 | | |
| 9.36 | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2022 | |
| 944,000 | | |
$ | 1.45 | | |
| 9.36 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2022 | |
| — | | |
| — | | |
| — | | |
| — | |
For
the nine months ended September 30, 2023, stock option activity for performance-based options of the Company are as follows:
| |
Number
of Performance- Based Share Options | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining Contractual Life
(in years) | | |
Aggregate Intrinsic Value | |
Outstanding
at January 1, 2023 | |
| 944,000 | | |
$ | 1.45 | | |
| 9.11 | | |
$ | 174,000 | |
Issued | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired/Forfeited | |
| (49,500 | ) | |
| — | | |
| — | | |
| — | |
Outstanding
at September 30, 2023 | |
| 894,500 | | |
$ | 1.41 | | |
| 8.36 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Vested
and exercisable September 30, 2023 | |
| — | | |
| — | | |
| — | | |
| — | |
|
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v3.23.3
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
|
|
|
|
Net loss |
$ 598,525
|
$ 899,125
|
$ 1,804,622
|
$ 2,767,885
|
|
Accumulated deficit |
$ 6,275,903
|
|
$ 6,275,903
|
|
$ 4,471,281
|
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- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Abstract] |
|
|
Computer equipment |
$ 10,999
|
$ 10,999
|
Less: Accumulated depreciation |
6,044
|
3,321
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Equipment, net |
$ 4,955
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$ 7,678
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SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Corporate bonus |
$ 272,603
|
$ 369,528
|
Legal expense |
147,006
|
124,245
|
Other |
45,894
|
24,852
|
Total accrued expenses |
$ 465,503
|
$ 518,625
|
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v3.23.3
NOTE PAYABLE (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
|
Jun. 01, 2023 |
May 20, 2023 |
Aug. 31, 2023 |
Sep. 30, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
Monthly payments |
$ 30,822
|
|
|
|
Notes payable |
|
|
|
$ 112,752
|
Maximum [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Monthly payments |
|
|
$ 30,822
|
|
Minimum [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Monthly payments |
|
|
$ 18,792
|
|
Directors and Officers Liability Insurance Agreement [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Insurance agreement |
|
$ 372,880
|
|
|
Monthly payments |
|
$ 75,000
|
|
|
Annual percentage rate |
|
7.50%
|
|
|
X |
- DefinitionFace (par) amount of debt instrument at time of issuance.
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v3.23.3
LICENSE (Details Narrative)
|
|
9 Months Ended |
Nov. 09, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2023
EUR (€)
|
Exchange rate, description |
|
converted from EUROS to USD using exchange
rate of €1:$1.0675
|
converted from EUROS to USD using exchange
rate of €1:$1.0675
|
Stem PrintER [Member] |
|
|
|
Extended regulatory approval or clearance of licensed product term |
36 months
|
|
|
Additional extended term for commercial launch |
60 months
|
|
|
Payments for license |
$ 175,000
|
|
|
Commercial Test [Member] |
|
|
|
Milestone payment |
|
$ 53,375
|
€ 50,000
|
Licensed Product [Member] |
|
|
|
Milestone payment |
|
106,750
|
100,000
|
US Market Approval [Member] |
|
|
|
Milestone payment |
|
$ 160,125
|
€ 150,000
|
X |
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v3.23.3
SCHEDULE OF LOSS PER SHARE (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
Net Loss |
$ (598,525)
|
$ (899,125)
|
$ (1,804,622)
|
$ (2,767,885)
|
Net loss per share attributable to common stockholders |
$ (598,525)
|
$ (899,125)
|
$ (1,804,622)
|
$ (2,767,885)
|
Weighted-average common shares outstanding, basic |
11,346,535
|
11,337,668
|
11,346,535
|
10,904,423
|
Weighted-average common shares outstanding, diluted |
11,346,535
|
11,337,668
|
11,346,535
|
10,904,423
|
Net loss per share attributable to common stockholders, basic |
$ (0.05)
|
$ (0.08)
|
$ (0.16)
|
$ (0.25)
|
Net loss per share attributable to common stockholders, diluted |
$ (0.05)
|
$ (0.08)
|
$ (0.16)
|
$ (0.25)
|
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SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE (Details) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
1,611,115
|
1,747,811
|
1,611,115
|
1,747,811
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
1,261,115
|
1,397,811
|
1,261,115
|
1,397,811
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
350,000
|
350,000
|
350,000
|
350,000
|
X |
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v3.23.3
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of Options, Issued |
0
|
0
|
0
|
|
|
|
Time Based Options [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of Options, Beginning Balance |
|
|
416,115
|
100,005
|
100,005
|
|
Weighted Average Exercise Price, Beginning |
|
|
$ 1.86
|
$ 0.42
|
$ 0.42
|
|
Weighted Average Remaining Contractual Life (in years) |
|
|
8 years 4 months 24 days
|
9 years 3 months 18 days
|
9 years 1 month 17 days
|
9 years 8 months 19 days
|
Aggregate Intrinsic Value Beginning |
|
|
$ 57,207
|
|
|
|
Number of Options, Issued |
|
|
|
363,239
|
|
|
Weighted Average Exercise Price, Issued |
|
|
|
$ 2.07
|
|
|
Weighted Average Remaining Contractual Life (in years), Issued |
|
|
|
9 years 5 months 4 days
|
|
|
Number of Options, Exercised |
|
|
|
(9,433)
|
|
|
Weighted Average Exercise Price, Exercised |
|
|
|
$ 0.90
|
|
|
Number of Options, Exercised/Forfeited |
|
|
(49,500)
|
|
|
|
Weighted Average Exercise Price, Expired/Forfeited |
|
|
$ 2.13
|
|
|
|
Number of Options, Ending Balance |
366,615
|
453,811
|
366,615
|
453,811
|
416,115
|
100,005
|
Weighted Average Exercise Price, Ending |
$ 1.82
|
$ 1.70
|
$ 1.82
|
$ 1.70
|
$ 1.86
|
$ 0.42
|
Aggregate Intrinsic Value Ending |
$ 27,384
|
$ 16,672
|
$ 27,384
|
$ 16,672
|
$ 57,207
|
|
Number of Options, Vested and exercisable, Ending Balance |
119,765
|
207,825
|
119,765
|
207,825
|
|
|
Weighted Average Exercise Price, Vested and exercisable, Ending Balance |
$ 1.29
|
$ 1.20
|
$ 1.29
|
$ 1.20
|
|
|
Weighted Average Remaining Contractual Life (in years) Vested and exercisable |
|
|
8 years 2 months 19 days
|
9 years 1 month 20 days
|
|
|
Aggregate Intrinsic Value, Vested and exercisable, Ending Balance |
$ 27,384
|
$ 16,672
|
$ 27,384
|
$ 16,672
|
|
|
Performance Based Options [Member] |
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
Number of Options, Beginning Balance |
|
|
944,000
|
|
|
|
Weighted Average Exercise Price, Beginning |
|
|
$ 1.45
|
|
|
|
Weighted Average Remaining Contractual Life (in years) |
|
|
8 years 4 months 9 days
|
9 years 4 months 9 days
|
9 years 1 month 9 days
|
|
Aggregate Intrinsic Value Beginning |
|
|
$ 174,000
|
|
|
|
Number of Options, Issued |
|
|
|
944,000
|
|
|
Weighted Average Exercise Price, Issued |
|
|
|
$ 1.45
|
|
|
Weighted Average Remaining Contractual Life (in years), Issued |
|
|
|
9 years 4 months 9 days
|
|
|
Number of Options, Exercised |
|
|
|
|
|
|
Weighted Average Exercise Price, Exercised |
|
|
|
|
|
|
Number of Options, Exercised/Forfeited |
|
|
(49,500)
|
|
|
|
Weighted Average Exercise Price, Expired/Forfeited |
|
|
|
|
|
|
Number of Options, Ending Balance |
894,500
|
944,000
|
894,500
|
944,000
|
944,000
|
|
Weighted Average Exercise Price, Ending |
$ 1.41
|
$ 1.45
|
$ 1.41
|
$ 1.45
|
$ 1.45
|
|
Aggregate Intrinsic Value Ending |
|
|
|
|
$ 174,000
|
|
Number of Options, Vested and exercisable, Ending Balance |
|
|
|
|
|
|
Weighted Average Exercise Price, Vested and exercisable, Ending Balance |
|
|
|
|
|
|
Aggregate Intrinsic Value, Vested and exercisable, Ending Balance |
|
|
|
|
|
|
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v3.23.3
SCHEDULE OF WARRANTS OUTSTANDING (Details) - Warrant [Member] - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Outstanding Number of Shares, Beginning balance |
350,000
|
|
|
Weighted Average Exercise Price, Beginning |
$ 1.06
|
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Aggregate intrinsic value - beginning |
|
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|
350,000
|
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|
$ 1.06
|
|
Weighted Average Remaining Contractual Terms, Issued |
|
9 years 3 months 25 days
|
|
Outstanding Number of Shares, Exercised |
|
|
|
Weighted Average Exercise Price, Exercised |
|
|
|
Outstanding Number of Shares, Expired/Forfeited |
|
|
|
Weighted Average Exercise Price, Expired/Forfeited |
|
|
|
Outstanding Number of Shares, Ending balance |
350,000
|
350,000
|
350,000
|
Weighted Average Exercise Price, Ending |
$ 1.06
|
$ 1.06
|
$ 1.06
|
Weighted Average Remaining Contractual Terms |
8 years 3 months 25 days
|
9 years 3 months 25 days
|
9 years 25 days
|
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|
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Number of Shares, Vested and exercisable |
|
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|
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|
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v3.23.3
SHARE-BASED COMPENSATION (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Stock option granted |
0
|
0
|
|
0
|
|
Share based compensation |
$ 19,900
|
$ 38,001
|
|
$ 58,735
|
$ 92,629
|
Expected dividend yield |
|
|
|
|
|
Unrecognized compensation expense |
$ 772,580
|
|
|
$ 772,580
|
|
Number of warrant issued |
0
|
0
|
|
0
|
0
|
Warrant [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Weighted average grant date fair value |
|
|
|
$ 0.66
|
|
Expected dividend yield |
|
|
|
|
|
Warrant fair value |
|
|
|
$ 232,490
|
|
Share-based compensation expense |
$ 0
|
$ 0
|
|
0
|
$ 0
|
Unrecognized compensation expenses |
232,490
|
|
|
$ 232,490
|
|
Time Based Options [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Stock option granted |
|
|
|
|
363,239
|
Options grant exercise price |
|
|
|
|
$ 2.07
|
Unrecognized compensation expense |
102,213
|
|
|
$ 102,213
|
|
Unrecognized compensation expense, recognized period |
|
|
|
2 years 7 months 6 days
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Weighted average grant date fair value |
|
|
|
|
$ 0.76
|
Performance Based Options [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Stock option granted |
|
|
|
|
944,000
|
Options grant exercise price |
|
|
|
|
$ 1.45
|
Unrecognized compensation expense |
$ 670,368
|
|
|
$ 670,368
|
|
Incentive Plan [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Shares authorized |
2,500,000
|
|
|
2,500,000
|
|
Number of shares available for grant |
1,229,452
|
|
|
1,229,452
|
|
Incentive Plan [Member] | Employees Directors And Non Employees [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Stock option granted |
|
|
1,307,239
|
|
|
Incentive Plan [Member] | Employees Directors And Non Employees [Member] | Minimum [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Options grant exercise price |
|
|
$ 1.06
|
|
|
Incentive Plan [Member] | Employees Directors And Non Employees [Member] | Maximum [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Options grant exercise price |
|
|
$ 2.13
|
|
|
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|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Number of warrant issued |
|
|
350,000
|
|
|
Warrant exercise price |
$ 1.06
|
|
|
$ 1.06
|
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v3.23.3
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
Nov. 13, 2023 |
Jan. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Proceeds from related party debt |
|
|
|
|
$ 940,665
|
$ 59,305
|
|
Related Party [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Related party costs |
|
|
$ 4,955
|
$ 4,708
|
|
|
|
Tiziana [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Due to affiliate |
|
|
1,016,894
|
|
1,016,894
|
|
$ 76,229
|
Tiziana [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Additional expenses |
$ 70,000
|
|
|
|
|
|
|
Gabriele Cerrone [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Due to affiliate |
|
|
$ 115,500
|
|
$ 115,500
|
|
|
Proceeds from related party debt |
|
$ 5,500
|
|
|
|
|
|
Tiziana [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Ownership percentage |
|
|
11.80%
|
|
11.80%
|
|
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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